Insights
RIMS implementation for a global leader in pharmaceutical and biosimilars
Situation
One of the major pharma companies planned to introduce an integrated regulatory information management (RIM) system to address submission management, dossier management and registration management, and to fulfil the structured data submissions in the European Union. As part of the implementation, the client was looking for support in choosing the right RIM system for their business needs. Additionally, there were concerns regarding the quality of business processes within the organization, creating a need for improved current business processes as part of the RIMS implementation.
Solution
- From project kick-off, Infosys Consulting collaborated with client’s regulatory leaders and SMEs and created the “to-be” process business maps. With our business process expertise, we simplified the client processes and made them more efficient.
- We provided technical help in training and coaching the client technical staff on xEVMPD, IDMP, and DADI-related topics which helped them to assess the future structured data submission requirements.
- Our team designed a RIMS vendor qualification assessment framework and supported various business topic demo sessions conducted by several RIMS vendors.
- With our functional and technical knowledge, we performed vendor scoring. We also liaised with the business to create the vendor scorecards for both RFP written responses and demo responses.
- We offered business process expertise support on the product management lifecycle for both generic pharmaceuticals and biosimilars. This was inclusive of pharmaceuticals, biologics, and medical devices followed by implementation of SDS for the IDMP roadmap.
- Our team documented and translated business process requirements as user stories to support the RIMS implementation.
